REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System… — Class II medical device recall Z-1953-2013
Terminated recall by Zimmer, Inc., reported 2013-08-21, distributed nationwide. There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during us
| Recall number | Z-1953-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-06-28 |
| Classified | 2013-08-12 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, IL, IN, IT, KR, LB, MT, NL, NO, PT, SE, SG, TH, TW |
| Quantity | 3,163 |
| Reason classes | device malfunction |
| Model numbers | 00-4309-071-36 |
Product
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
Reason for recall
There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1953-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.